Identity
- Trade Name
- AdvanTrode FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Butterfly w/ Lead Connector FDA UDI
- Model / Reference
- 800FLY-PIN FDA UDI
- Description
- Butterfly w/ Lead Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00677346310737 FDA UDI
- 510(k) Number
- K070807 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
AdvanTrode by Pepin Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transcutaneous electrical stimulation electrode, single-use.
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Cleared under the same submission
K070807 also covers:
- 4 x 6 Foam Butterfly Electrodes — Emsi
- EMSI ButterFly Electrical Stimulation Electrode — Emsi
- EMSI Large Velcro Electrical Stimulation Electrode — Emsi
- TMR-ELEC-17501442 — Emsi
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
- AdvanTrode — PEPIN MANUFACTURING, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pepin Manufacturing, Inc.
Sources (1)
- FDA UDI 5ef4314d-cbc1-4454-9147-7ebf9d9af1fd 34 fields · synced May 30, 2026